TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Safetec of America, Inc.

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61010-5603,Triple Antibiotic Ointment™

Drug Facts

Active Ingredient (in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Purposes

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use:

Ask a doctor before use:

Stop use and ask a doctor if:

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

Directions

Other Information

Inactive Ingredient

Petrolatum

Questions or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 • 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label

PRINCIPAL DISPLAY PANEL – Box Label

NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

PRINCIPAL DISPLAY PANEL – Box Label
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-5603-4144 in 1 BOX03/30/2007
1NDC:61010-5603-20.5 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00403/30/2007
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(61010-5603)

Revised: 2/2024
Document Id: 10d3b150-07a5-cb76-e063-6394a90ab356
Set id: 2c2aa8af-2adb-4f59-ac20-15818d0e28e7
Version: 5
Effective Time: 20240207
 
Safetec of America, Inc.